NCT07556796Active, not recruitingPhase 1
Study of IBI3016 in People With Mild or Moderate Hypertension Patients
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Features of a Single Subcutaneous Administration of IBI3016 in Patients With Mild or Moderate Hypertension in China
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 14 Apr 2026
- Start date
- 8 May 2026
- Primary completion date
- 16 Oct 2027
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT07556796
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 8 May 2026 to the primary completion date, 16 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening, or a previous diagnosis of decompensated heart failure or New York Heart Association (NYHA) grade III or IV heart failure.
- Other protocol-defined inclusion/exclusion criteria may apply
Other illness
- Known history of secondary hypertension.
- Current or history of intolerance to ACEi and/or ARBs.
Lab values
- Laboratory parameter assessments outside of range at screening:
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2× Upper Limit of Normal (ULN)
- Total Bilirubin \> 1.5× ULN
- International Normalized Ratio (INR) \> 2.0
- Serum Potassium \> 5 mmol/L
- Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²
- QTcF \> 480 ms
Other
- Orthostatic hypotension.
Who the study is looking for
- Signed informed consent.
- Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent.
- 4.Mean sitting SBP ≥140 mmHg and \< 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.